Regulatory Affairs Manager

Optimus Search Limited
£80k pa + Share Package, Add. Nenefits
30 Sep 2017
15 Oct 2017
Contract Type
Full Time
Job Title: Senior Regulatory Manager Location: Birmingham Job Type: Permanent/ Long Term Contract Salary: Competitive Optimus Life Sciences are looking for an experienced Senior Regulatory Manager for an innovative medical device company. My client is looking for a submissions specialist to strengthen their regulatory team. Overview Main responsibility: To develop a regulatory strategy to support all target markets, and to maintain regulatory compliance as required. Key Responsibilities * To drive the company to deliver sufficient depth of evidence to demonstrate regulatory compliance. * To drive the vigilance processes (PMS feedback, regulatory changes, adverse events, competitor information, literature searches) required in Europe, US and other relevant markets. * To deliver PMS report, Vigilance Report and clinical evaluation report in line with the relevant plans. * To define the appropriate regulatory pathways for entry into global markets and support other members of the company in understanding the regulatory pathways. * To provide advice on possible approaches to de-risking and accelerating project completion. * To provide advice on approaches taken by other companies for comparable products in satisfying regulatory requirements. * To provide risk assurance support into the design and development process, to assure risk consideration and acceptability as ALAP throughout the product development lifecycle. * To provide managerial leadership for RA team members, ensuring that there is a common agreement on strategy, priorities and deadlines, and to maintain a strong understanding of delivery against plans and targets. Requirements/Qualifications * Strong understanding of regulatory standards and their implementation in a Medical Device framework i.e. Medical Device Directive (93/42EEC), ISO 13485, ISO 14971, IEC 60601,IEC 62366, IEC 62304, 21 CFR 820,21CFR 807, 21 CFR 11. * Experience in working with PEMS (Programmable Electrical Medical Systems) or equivalent high-integrity software-intensive systems i.e. complex devices requiring multidisciplinary development effort (mechanical engineering, software, electronics, system integration, pneumatics, fluid mechanics, etc.). desirable * Experience of working with risk management, regulatory requirements, document management systems, issue management systems. * Trained in application of IS014971. * Ability to work with external bodies. * Good team player and effective communicator. * Flexible approach to hours. * Ability to operate at strategic and operational levels. * Ability to identify strategic and operational issues and develop plans to address. * Ability to lead; demonstrating assertiveness, team building and management skills. * Attention to detail. * Effective communicator. * Articulate, persuasive personality. * At least 10 years of experience working in product development & delivery. * Sound technical knowledge of product base and application. * Degree or equivalent experience in appropriate subjects. Don't miss out on this opportunity to join an exciting project at a great company. My client is looking to fill this role quickly- don't miss the opportunity to gain experience at a managerial level and challenge yourself further. Email your CVs to [Email address removed]
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